A Prospective Cohort Study for Patients With Adrenal Diseases

Pheochromocytoma Clinical Trial

Official title:

A Prospective Cohort Study for Patients With Adrenal Diseases

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03474237
• Other study ID #: 1801-010-911
• Status: Enrolling by invitation
• Start date: October 1, 2018
• Est. completion date: December 31, 2027

Study information

• Verified date: March 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to investigate the pathologic features, complications, and prognostic factors of functioning adrenal adenoma and suggest follow-up algorithms for adrenal incidentaloma.

Description:

The investigators will recruit 150 patients annually for 10 years (adrenal incidentaloma 100 patients, pheochromocytoma 15 patients, primary aldosteronism 25 patients, adrenal cushing syndrome 10 patients, adrenocortical carcinoma 2 patients) and perform hormonal, biochemical, imaging exam according to each disease's clinical guidelines. Based on this, the investigators will identify pathologic features, complications, and prognostic factors of each disease.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1500
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Adults, male or female aged 19 years or older

• newly diagnosed with adrenal disease such as adrenal incidentaloma, pheochromocytoma, primary aldosteronism, adrenal cushing syndrome, adrenocortical carcinoma

Exclusion Criteria:

• previous or current history of adrenal diseases

• using oral or intravenous steroids

• history of major depressive disorder

• history of chronic alcoholics

• history of any cancer with suspicious adrenal metastasis

• those with acute illness (ex- patients with acute coronary syndrome within 4 weeks, acute febrile disease)

Related Conditions & MeSH terms

• Adenoma
• Adrenal Adenoma
• Adrenal Incidentaloma
• Adrenocortical Adenoma
• Adrenocortical Carcinoma
• Cushing Syndrome
• Hyperaldosteronism
• Pheochromocytoma
• Primary Hyperaldosteronism

Intervention

Other:
• Hormone study and Imaging study
Blood (basal hormone and follow up hormone study) Imaging examination including computed tomography scan or magnetic resonance imaging

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants in remission	Remission rate	Up to 10 years
Secondary	Complication of adrenal disease	all complications including deaths	Up to 10 years